Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures (a type of epilepsy of fits).

A Randomized, Multicenter, Double-Blind, Placeboâ??Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/01/002344

Enrollment

270

Registered

2012-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Refractory Partial-Onset Seizures

Interventions

Intervention1: Drug: USL255: From 50mg QD increased upto 200mg QD (15 Weeks) Control Intervention1: Drug: Placebo: 15 Weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1. 2. Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone). 3. Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion criteria

Exclusion criteria: 1. Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1. 2. Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1. 3. Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma. 4. Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1. 5. Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past. 6. Have taken topiramate within the past 6 months.

Design outcomes

Primary

Measure	Time frame
Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase. Timepoint: Weekly (7 day)	—

Secondary

Measure	Time frame
Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase.Timepoint: Weekly;Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.Timepoint: Weekly;Proportion of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase compared to baseline.Timepoint: Weekly;Proportions of subjects with greater than or equal 25 percent, greater than or equal 75 percent, and 100 percent reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately.Timepoint: Weekly;Proportions of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.Timepoint: Weekly	—

Measure

Time frame

Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase.Timepoint: Weekly;Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.Timepoint: Weekly;Proportion of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase compared to baseline.Timepoint: Weekly;Proportions of subjects with greater than or equal 25 percent, greater than or equal 75 percent, and 100 percent reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately.Timepoint: Weekly;Proportions of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.Timepoint: Weekly

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Countries

Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russian Federation, South Africa, Spain, United States of America

Contacts

Public ContactArun Sundriyal

PPD Pharmaceutical Development India Pvt. Ltd.

Arun.Sundriyal@ppdi.com911244739903

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026